Skin Closure Devices with Self-Forming Exudates Drainage Channesl

ABSTRACT

A device for application onto wounds with a liquid rapidly polymerizable adhesive for forming skin closure systems, comprising a thin flexible flat porous tape, preferably a mesh, elongated along a longitudinal axis and having a lower side or wound-facing side and an opposing upper side, a periphery, and central portion in immediate vicinity of the axis; said tape coated or impregnated with an initiator or accelerator of polymerization; said tape having a plurality of elongated traces of soluble pressure sensitive adhesive (PSA) disposed on the wound-facing side; said traces covering from about 3% to about 50% of area of said tape and extending from the periphery to the central portion of said tape.

The present disclosure relates to skin closure devices applied over asurgical incision and preferably secured by a polymerizable adhesive,with the devices capable of forming drainage channels for removal ofwound exudates.

BACKGROUND

A number of devices and methods exist for closing skin or tissue havinga surgical incision, opening, cut, wound, or dissection. With thesedevices, skin or tissue parts separated by the incision are approximatedor brought into close proximity forming as narrow a gap as possible inthe area of the surgical incision or cut, and then covered by anadhesively attached tape which holds the skin or tissue in closedapposed arrangement until wound healing occurs after which the tape isremoved.

Commercially available DERMABOND® PRINEO® Skin Closure System comprisesa mesh having a pressure sensitive adhesive and a polymerizationinitiator disposed on the mesh. The mesh is applied onto the skin over awound, and a polymerizable cyanoacrylate-based adhesive is then appliedon the mesh and bonds the mesh to the skin.

However, skin closure systems may benefit from means to enable removaland drainage of wound exudates for wounds closed using skin closuresystems, when required. Because skin closure systems seal the woundtightly, it can be beneficial to relieve any exudate pressure buildup orminimize the onset of skin maceration when the amount of exudates issignificant.

U.S. Patent Application Publication No. 20140107561 “COMPRESSIVE OXYGENDIFFUSIVE WOUND DRESSINGS” discloses a wound dressing, comprising: anoxygen-diffusive substrate defining a contact surface; and, ahydrophilic absorbent material in fluid communication with at least oneportion of a periphery of the oxygen-diffusive substrate, wherein atleast one portion of the substrate is configured to press the contactsurface against a wound surface.

U.S. Patent Application Publication No. 20130274717 “SURGICAL CAVITYDRAINAGE AND CLOSURE SYSTEM” discloses a surgical drain devicecomprising a plurality of drain tubes positioned with an adhesionmatrix, the adhesion matrix having a wound conforming shape andcomprising a plurality of apertures for tissue contact through thematrix, the drain tubes being removable from the device and the adhesionmatrix comprising a biodegradable polymer.

U.S. Patent Application Publication No. 20050085757 “EXPANDABLETEMPORARY ABDOMINAL CLOSURE” discloses an abdominal and thoracic closuresystem comprising: a sterilizable flexible sheet comprising: aperipheral portion attachable to skin or fascia about a wound; and acentral expandable portion allowing expansion of the abdomen or thoraxwhile providing a continuous covering of a wound in the abdomen by theflexible sheet.

U.S. Patent Application Publication No. 20130066365 “RAPID CLOSINGSURGICAL CLOSURE DEVICE” discloses a wound closure device, comprising: afirst adhesion patch configured for adhering to a patient's skin; asecond adhesion patch configured for adhering to the patient's skin; thewound closure device having an open position with an approximatelyelliptical shaped opening formed between the first adhesion patch andthe second adhesion patch and a closed position wherein the firstadhesion patch and the second adhesion patch are held in close proximityto each other.

U.S. Pat. No. 8,884,094 “VACUUM BANDAGE PACKING” discloses a vacuumbandage connectable to a source of fluid and provided for use with awound having a wound surface, the bandage comprising: a wound dressingmember having a wound contacting surface, a top surface, a portconfigured for fluid communication with the source of fluid, holes inthe wound contacting surface configured for communication with a woundsurface of the wound, and a passageway between the port and the holes,and a pack adjacent the top surface of the wound dressing member andhaving an aperture positioned about the port.

U.S. Pat. No. 9,381,284 “SYSTEM AND METHOD FOR SEALING AN INCISIONALWOUND” discloses a method for treating an incisional wound havingincisional walls, the method comprising: fluidly coupling a conduit to asource of reduced pressure, the conduit having a first end for receivingreduced pressure and a second end; fluidly coupling a scaffold to thesecond end of said conduit for receiving the reduced pressure, whereinthe scaffold is formed from sufficiently thin porous material having aninternal manifold extending generally longitudinally between opposingsurfaces of the scaffold, the internal manifold having a primary flowchannel comprised of bioresorbable tubing; positioning the opposingsurfaces of the scaffold between the incisional walls of the incisionalwound; fluidly coupling the internal manifold to the second end of theconduit for receiving the reduced pressure; surgically closing theincisional wound to maintain the reduced pressure therein; and providingthe reduced pressure through the conduit to the scaffold and theinternal manifold for the incisional wound, whereby the scaffold inducestissue apposition between the incisional walls.

U.S. Patent Application Publication No. 20100298791 “METHODS ANDAPPARATUSES FOR THE TREATMENT OF WOUNDS WITH PRESSURES ALTERED FROMATMOSPHERIC” discloses an altered pressure device for treating a woundin an encapsulated space delimited by a cover secured over a wound, thedevice comprising: (a) an altered pressure source communicating with theencapsulated space via a length of tubing coupled with the source; and(b) layered intermediate materials composed of at least one foam layerand a top layer that is not foam, said non-foam layer in contact withthe cover, wherein the top layer comprises structural characteristicsthat provide efficient gas permeation into the encapsulated space wheninterfacing with the cover.

Skin closure devices and dressings having porated or porous or aperturedtape structure can release the pressure of wound exudates and providefor drainage, however these systems will also leave the incision andwound open to ingress of contaminates through the pores or apertures,potentially resulting in infection. There continues to be a need forimproved devices, systems, and methods for holding skin areas around thedissection in apposed arrangement and covered and isolated from ingressof contaminants, while still providing for drainage of exudates.

SUMMARY OF THE INVENTION

In one embodiment, the invention relates to a device for applicationonto incisions or wounds with a liquid rapidly polymerizable adhesivefor forming skin closure systems, comprising a thin flexible flat poroustape, preferably a mesh, elongated along a longitudinal axis and havinga lower side or wound-facing side and an opposing upper side, aperiphery, and central portion in immediate vicinity of the axis; saidmesh coated or impregnated with an initiator or accelerator ofpolymerization; said mesh having a plurality of elongated traces ofsoluble pressure sensitive adhesive (PSA) disposed on the wound-facingside; said traces covering from about 3% to about 50% of area of saidtape and extending from central portion to the periphery of said tape.

According to another embodiment, a method is provided of using thedevice for application onto incisions or wounds with a liquid rapidlypolymerizable adhesive for forming skin closure systems on a wound forskin incision closure, comprising the steps: positioning a devicecomprising soluble PSA disposed on the wound-facing side of the device;orienting the axis of the device in alignment with the incision ensuringthe axis is approximately overlapping the incision; approximating edgesof the incision to each other with the device and adhering the device tothe skin; applying a polymerizable adhesive onto the upper side of thetape, allowing the adhesive to penetrate through the tape and contactthe skin; allowing the adhesive to react with the initiator oraccelerator of polymerization and polymerize thus bonding the tape tothe skin; allowing exudate from the wound to at least partially dissolvethe traces of soluble pressure sensitive adhesive (PSA) thus formingdrainage channels; providing coverage of the incision and keeping theincision closed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1a-e show embodiments of the skin closure device in schematicbottom views.

FIG. 2 shows an embodiment of the skin closure device in a schematicbottom view.

FIGS. 3a-d show embodiments of the skin closure device in schematicbottom views.

FIGS. 4a-b show embodiments of the skin closure device in schematicbottom views.

FIGS. 5a-c show embodiments of the skin closure device in schematiccross-sectional views during use of the device.

FIGS. 6a-b show embodiments of the skin closure device in schematic topviews and illustrates formation of drainage channels.

FIG. 7 shows an embodiment of the skin closure device in a schematic topview.

FIGS. 8a-d show embodiments of the skin closure device in schematiccross-sectional views during use of the device.

DETAILED DESCRIPTION

According to embodiments of the present invention, self-forming drainagechannels are provided to remove exudates and allow drainage from thewound or surgical incision towards the periphery of the skin closuresystem.

Referring now to FIGS. 1 a-e, embodiments of skin closure system device10 are shown in a schematic view from a lower side 23, with device 10comprising a thin, flat, flexible porous tape 20, (depicted as a mesh inall Figs.) having length L and width W and elongated along longitudinalaxis 21, with upper side 22 (not visible in views of FIG. 1 but visiblefor instance in FIG. 5) and lower or wound facing side 23. Tape 20comprises a porous tape having perforations or micro-holes throughoutand can be a woven, non-woven, extruded, punched, perforated, molded,etc. substrate. Preferably tape 20 is a mesh and coated and/orimpregnated with an initiator or accelerator of polymerization.

On lower side 23, which is the tissue or skin facing side of device 10,there is a plurality of elongated traces 30 of soluble pressuresensitive adhesive (PSA), said traces covering from 3% to about 50% ofthe area of tape 20, more preferably 5% to 40%, such as 5%, 10%, 20%,and extending from a central portion to periphery P of tape 20, thecentral portion being in the immediate vicinity of axis 21. Soluble PSAtraces 30 and 32 are configured to form channels for drainage ofexudates as will be discussed below.

Traces 30 originate close to axis 21 and terminate at periphery P.Traces 30 can be in a form of linear segments of soluble PSA and can rununder any angle to axis 21. As shown in FIG. 1a , traces 30 form anangle of about 60° to axis 21 in “V” shapes with the apex of “V” beingat axis 21. Other angles are possible such as angles from 20° to 90°,such as 30°, 45°, 90°, and similar.

As shown in FIG. 1b , in one embodiment, there is provided soluble PSAtrace 32 which runs along and at least partially overlaps axis 21, trace32 also connected with all traces 30 in a “fishbone” arrangement.

As shown in FIG. 1c , in one embodiment, traces 30 comprise straightlinear segments of soluble PSA and form a non-right angle to axis 21running from upper periphery P1 to opposing lower periphery P2.

As shown in FIG. 1d , in one embodiment, traces 30 comprise straightlinear segments of soluble PSA and form a right angle to axis 21 andruns from and overlaps the area of axis 21 area to upper periphery P1 inone direction and from axis 21 and overlapping with axis 21 to lowerperiphery P2 in the opposing direction.

As shown in FIG. 1e , in one embodiment, there is provided soluble PSAtrace 32 which runs along and at least partially overlaps axis 21, trace32 is also connected with all traces 30 which are only directed to upperperiphery P1, with no traces 30 directed to lower periphery P2.

In preferred embodiments, at least a portion of traces 30 and/or 32overlaps axis 21.

Referring now to FIG. 2, an embodiment of skin closure system device 10is shown in a schematic view of wound-facing side 23, with elongatedabsorbent pads 60 attached to tape 20 at periphery P1 and P2 of tape 20.Absorbent pads 60 are configured to absorb exudates which are movingfrom the surgical incision or wound around axis 21 via drainage channelsformed of soluble PSA traces 30 towards periphery P1 and P2. Absorbentpads 60 are made of any fluid-absorbing, biomedically compatiblematerial and are in contact with at least some drainage channels formedof soluble PSA traces 30.

PSA Reinforcing Zones

Referring now to FIGS. 3a-d , embodiments of skin closure system device10 are shown in a schematic view from wound-facing side 23, whereby inaddition to soluble PSA traces 30 and 32, there are provided additionaland optional PSA reinforcing zones 40, serving to improve attachment ofdevice 10 to skin but not configured for forming drainage channels toremove exudates from central portions of device 10 around axis 21 toperipheries P1, P2 of device 10. PSA reinforcing zone 40 can be made ofsoluble PSA, similar to traces 30, 32, or of insoluble PSA. PSAreinforcing zones 40 can terminate at periphery P1, P2 (not shown) or ata distance from periphery P1, P2 (as shown).

As shown in FIGS. 3a-c , PSA reinforcing zones 40 can comprise shortlinear segments of PSA positioned between traces 30 and not overlappingwith axis 21 and traces 30, 32.

As shown in FIG. 3d , PSA reinforcing zones 40 can comprise non-linearshapes, such as circular or elliptical shapes, with segments of PSApositioned between traces 30 and not overlapping with axis 21 and traces30, 32.

Referring now to FIGS. 4a-b , embodiments of skin closure system device10 are shown in a schematic view from wound-facing side 23, whereby inaddition to soluble PSA traces 30 and 32, there are provided additionalPSA reinforcing zones 45, serving to improve attachment of device 10 toskin but not configured for forming drainage channels to removeexudates. PSA reinforcing zones 45 in these embodiments is made ofinsoluble PSA, with linear segments of insoluble PSA positioned betweentraces 30 and optionally aligned with but not overlapping with and notoverlapping with traces 30, but optionally overlapping with axis 21.Insoluble PSA reinforcing zones 45 can terminate at periphery P1, P2 asshown in FIG. 4a-b or at a distance from periphery P1, P2 (not shown).

Optional PSA reinforcing zones 40, 45 may cover from 3% to about 50% ofarea of tape 20, more preferably 5% to 40%, such as 10%, 20%, 30%, 40%.

Soluble PSA traces 30 and 32 and optional PSA reinforcing zones 40, 45,in combination, may cover from about 5% to about 60% of area of mesh 20,more preferably 5% to 50%, such as 5%, 10%, 20%, 30%, 40%.

In Use

Referring now to FIGS. 5a-c , the embodiment of skin closure systemdevice 10 of FIG. 1d is shown in a schematic cross-sectional side viewas indicated by arrows on FIG. 1d . As shown in FIG. 5A, tape 20 ispositioned on skin 100 having a wound or surgical incision (not shown)with lower side 23 on which traces of soluble PSA 30, 32 (not shown) arelocated, facing towards skin 100 and with opposing upper side 22 facingaway from skin 100. Tape 20 is secured to skin by traces of soluble PSA30, and also by optional traces of soluble PSA 32 (not shown), and alsoby optional traces of soluble or insoluble PSA 40, 45 (not shown).

Optionally, tape 20 is used to approximate and hold in apposition orclose approximation the edges of surgical incision or wound, usingtraces of soluble PSA 30, optional traces of soluble PSA 32, and/oroptional traces of soluble or insoluble PSA 40, 45 for securing tape 20on skin 100 and for securing in close approximation or apposition theedges of surgical incision or wound.

The positioning of device 10 over the surgical incision or wound isperformed so that axis 21 is as much as possible aligned with thesurgical incision or wound and overlaps with the surgical incision orwound i.e., axis 21 is in registration the surgical incision or wound.

As shown in FIG. 5b , polymerizable or cross-linkable adhesive 50 isthen uniformly applied over the whole of tape 20 upper surface 22,penetrating through tape 20 and establishing contact with skin 100. Asshown, adhesive 50 does not contact skin 100 in the areas where solublePSA 30 is present. Adhesive 50 can be expressed from a container havinga porous tip impregnated with a polymerization or cross-linkingaccelerator or initiator. In a preferred embodiment, adhesive 50 isexpressed from an applicator not having polymerization or cross-linkingaccelerator or initiator, with such polymerization or cross-linkingaccelerator or activator/initiator present on or in tape 20 in areleasable or reactive form, i.e., available for rapid reaction whencontacted with adhesive 50.

Liquid adhesive 50 then polymerizes and/or cross-links and solidifies,establishing secure bond with skin 100 and tape 20. Advantageously,areas where traces of soluble PSA 30 are present are free of adhesive 50being in contact with skin and tape 20 and it is in these areas thatskin 100 only is only attached by traces of soluble PSA 30. Skin closureby device 10 is thus completed with surgical incision under tape 20securely covered and closed.

As shown in FIG. 5c , in cases when exudates are forming at the site ofsurgical incision, these exudates will at least partially dissolvetraces of soluble PSA 30. In these areas where traces of soluble PSA 30have dissolved, channels 30 a are formed in place of traces of solublePSA 30, creating narrow pathways or channels between skin 100 and tape20 impregnated and covered with adhesive 50. Thus channels 30 a areself-forming due to dissolution of traces of soluble PSA 30, 32 byexudate and generally follow the direction of traces of soluble PSA 30,32. Channels 30 a are narrow pathways between skin 100 and mesh 20covered with adhesive 50, with channels running under tape 20 and/orpartially through tape 20.

Referring now to FIGS. 6a-b , embodiments of device 10 are presented ina schematic top view from upper surface 22, after device 10 was appliedto skin 100, adhesive 50 applied on top and solidified, binding tape 20to skin 100, and after at least partial dissolution of traces of solublePSA 30 and 32, thus forming drainage channels 32 a along axis 21 (withaxis 21 being approximately above surgical incision which is not shown)and drainage channels 30 a running from the area around axis 21 andabove and adjacent to the surgical incision towards periphery of device10. FIG. 6a shows the embodiment of FIG. 1b with drainage channels 30 aterminating at the periphery of device 10. FIG. 6b shows the embodimentof FIG. 2, with drainage channels 30 a terminating at the periphery ofdevice 10 at absorbent pads 60. Arrows 110 schematically illustrate thedirection of exudate drainage from wound or incision areas adjacent axis21 towards periphery of device 10.

Shielding Film Embodiments

Referring now to FIG. 7, an alternative embodiment of device 10 ispresented, showing view from upper side 22, whereby non-solubleshielding film traces 70 are attached to upper side 22 of tape 20.Non-soluble shielding film traces 70 may cover from 3% to about 60% ofthe top surface area of tape 20, more preferably 5% to 30%, andextending from periphery P of tape 20 to a central portion of tape 20,the central portion being in the immediate vicinity of axis 21.Shielding film traces 70 are configured to form channels for drainage ofexudate by preventing the flow of polymerizable adhesive through tape 20at film traces 70 and are configured in geometry and shapes similar tosoluble PSA traces 30, 32 shown in FIGS. 1-4, inclusive. Shielding filmtraces 70 originate close to axis 21 and terminate at periphery P andcan be in a form of linear segments of any polymeric or paper film andcan run under any angle to axis 21, such as under angle to axis 21and/or in “V” shapes with apex of “V” being at or near axis 21. In someembodiments, there is provided shielding film trace 70 a (not shown)which runs along and at least partially overlaps axis 21, with suchtrace 70 a also connected with all traces 70 in a “fishbone”arrangement. In one embodiment, shielding film traces 70 comprisestraight linear segments of insoluble film, and run under a non-rightangle to axis 21 running from upper periphery P1 to opposing lowerperiphery P2. In one embodiment, as shown in FIG. 7, shielding filmtraces 70 comprise straight linear segments of shielding film positionedat right angles to axis 21 and extending from axis 21 area andoverlapping with axis 21 to upper periphery P1 in one direction and fromaxis 21 and overlapping with axis 21 to lower periphery P2 in opposingdirection. In one embodiment (not shown), there is provided a shieldingfilm trace 70 a which runs along and at least partially overlaps axis21, such trace 70 a also connected with all shielding film traces 70which are only directed to upper periphery P1, with no shielding filmtraces 70 directed to lower periphery P2.

In preferred embodiments, at least a portion of shielding film traces 70overlap axis 21.

In one embodiment (not shown), elongated absorbent pads 60 are attachedto at periphery P1 and P2 of tape 20. Absorbent pads 60 are configuredto absorb exudate which are moving from the surgical incision or woundaround axis 21 via drainage channels formed under shielding film traces70 towards periphery P1 and P2.

Soluble PSA Traces

In some embodiments, soluble PSA traces 30, 32 are positioned inregistration and alignment with non-soluble shielding film traces 70, 70a, with soluble PSA traces 30, 32 on lower side 23 immediately undercorresponding shielding film traces 70, 70 a on upper side 22 of tape20. Shapes and arrangements of soluble PSA traces 30, 32 may be the sameas shapes and arrangements of corresponding shielding film traces 70, 70a, with the same length but preferably with the width of shielding filmtraces 70, 70 a being from 100% to 200% of the width of correspondingsoluble PSA traces 30, 32, such as 100%, 120%, 150% of width ofcorresponding soluble PSA traces 30, 32.

PSA Reinforcing Zones

Embodiments of skin closure system device 10 are also disclosed wherebyin addition to shielding film traces 70, 70 a, there are providedadditional and optional PSA reinforcing zones 40, 45, serving to improveattachment of device 10 to skin but not configured for forming drainagechannels to remove exudate from central portions of device 10 aroundaxis 21 to periphery P1, P2 of device 10. Similar in configurations toembodiments of FIGS. 3a -d, 4 PSA reinforcing zones 40, 45 can be madeof soluble PSA, or of insoluble PSA. PSA reinforcing zones 40 canterminate at periphery P1, P2 or at a distance from periphery P1, P2.PSA reinforcing zones 40 can comprise short linear segments of PSApositioned between shielding film traces 70 and not overlapping withaxis 21 and shielding film traces 70. PSA reinforcing zones 40, 45 cancomprise non-linear shapes, such as circular or elliptical shapes, withsegments of PSA positioned between traces 30 and not overlapping withaxis 21 and traces 30, 32.

In Use

The embodiments of skin closure system device 10 of FIG. 7 are shown inFIGS. 8a-d in a schematic cross-sectional side view as indicated byarrows in FIG. 7.

As shown in FIG. 8A, shielding film traces 70 are attached on upper side22 of tape 20 and are configured to have width to prevent adhesive 50penetrating into the areas immediately under shielding film traces 70.In this embodiment, there are no soluble PSA traces 30 disposed on tape20, however there are traces of soluble or insoluble PSA 40 45? (notshown) for securement of tape 20 to skin 100.

As shown in FIG. 8b , shielding film traces 70 are attached on upperside 22 of tape 20 and are in registration with soluble PSA traces 30disposed on lower side 23 of tape 20, with shielding film traces 70configured to have larger width vs. soluble PSA traces 30.

In use, and referring to FIGS. 8c and 8d , similarly to description ofFIGS. 5a-c , tape 20 is positioned on skin 100 having a wound orsurgical incision (not shown) with lower side 23 facing towards skin 100and with opposing upper side 22 on which shielding film traces 70 areattached facing away from skin 100.

Tape 20 is secured to skin by optional traces of soluble PSA 30, andalso by optional traces of soluble PSA 32 (not shown), and also byoptional traces of soluble or insoluble PSA 40 45 (not shown).

Optionally, tape 20 is used to approximate and hold in apposition orclose approximation the edges of surgical incision or wound, usingtraces of soluble PSA 30, optional traces of soluble PSA 32, and/oroptional traces of soluble or insoluble PSA 40 45? for securing tape 20on skin 100 and for securing in close approximation or apposition theedges of surgical incision or wound.

The positioning of device 10 over the surgical incision or wound isperformed so that axis 21 is as much as possible aligned with thesurgical incision or wound and overlaps with the surgical incision orwound i.e., axis 21 is in registration the surgical incision or wound.

As shown in FIG. 8c , whereby embodiment of FIG. 8a is presented in use,polymerizable or cross-linkable adhesive 50 is then uniformly appliedover the whole mesh 20 upper surface 22, penetrating through tape 20 andestablishing contact with skin 100. As shown, adhesive 50 does notcontact skin 100 in the areas where shielding film traces 70 arepresent. Adhesive 50 can be expressed from a container having a poroustip impregnated with a polymerization or cross-linking accelerator orinitiator. In a preferred embodiment, adhesive 50 is expressed from anapplicator not having polymerization or cross-linking accelerator orinitiator, with such polymerization or cross-linking accelerator oractivator/initiator present on or in tape 20 in a releasable or reactiveform, i.e., available for rapid reacting when contacted with adhesive50.

Liquid adhesive 50 then polymerizes and/or cross-links and solidifies,establishing secure bond with skin 100 and mesh 20. Advantageously,areas where shielding film traces 70 are present are free of adhesive 50being in contact with skin, with channels 30 b forming under shieldingfilm traces 70, creating narrow pathways or channels between skin 100and tape 20 impregnated and covered with adhesive 50. Thus channels 30 bare self-forming under shielding film traces 70. Channels 30 b arenarrow pathways between skin 100 and mesh 20 covered with adhesive 50,with channels 30 b running under tape 20 and/or partially through tape20.

As shown in FIG. 8d , whereby embodiment of FIG. 8b is presented in use,polymerizable or cross-linkable adhesive 50 is then uniformly appliedover the whole of tape 20 upper surface 22, penetrating through tape 20and establishing contact with skin 100. As shown, adhesive 50 does notcontact skin 100 in the areas where shielding film traces 70 and solublePSA 30 are present. Adhesive 50 can be expressed from a container havinga porous tip impregnated with a polymerization or cross-linkingaccelerator or initiator. In a preferred embodiment, adhesive 50 isexpressed from an applicator not having polymerization or cross-linkingaccelerator or initiator, with such polymerization or cross-linkingaccelerator or activator/initiator present on or in mesh 20 in areleasable or reactive form, i.e., available for rapid reacting whencontacted with adhesive 50.

Liquid adhesive 50 then polymerizes and/or cross-links and solidifies,establishing secure bond with skin 100 and tape 20. Advantageously,areas where shielding film traces 70 and soluble PSA 30 are present arefree of adhesive 50 being in contact with skin. Channels 30 b are formedunder shielding film traces 70 and upon dissolution of soluble PSA 30,as exudates forming at the site of surgical incision at least partiallydissolve traces of soluble PSA 30, creating narrow pathways or channelsbetween skin 100 and tape 20 impregnated and covered with adhesive 50.Thus channels 30 b are self-forming under shielding film traces 70.Channels 30 b are narrow pathways between skin 100 and tape 20 coveredwith adhesive 50, with channels 30 b running under tape 20 and/orpartially through tape 20.

Sizes/Dimensions

Tape 20 can be of any elongated shape to cover an articulating joint,such as elliptical, rectangular, and similar. Tape 20 can have ratio oflength to width of about 1:2 to about 1:20, such as 1:5. The length oftape 20 is from about 10 cm to about 50 cm, such as 25 cm. The width oftape 20 is from 2 cm to 10 cm, such 3 cm, 5 cm.

Porosity of tape 20 is defined by size of pores or holes being fromabout 0.01 mm² to about 4 mm², more preferably 0.1 mm² to 1 mm². Percentof open area in tape 20, or ratio of area of holes to area of materialsurrounding holes is from about 95%-about 20%, more preferably 90%-40%constituting open area.

Elongated traces 30, 32 of soluble pressure sensitive adhesive (PSA)have width from about 0.5 mm to about 7 mm, more preferably 1 mm to 5mm, such as 1, 1.5, 2, 3, 4 mm. The length of elongated traces 30 isfrom about 50% of the width of tape 20 to about 300% of the width ofmesh 20, such as 10, 15, 20, 30, 40, 50, 60 mm. The length of elongatedtraces 32 is from about 50% to about 100% of the length of tape 20, suchas 50, 100, 200, 300 mm.

PSA reinforcing zones 40, 45 can be linear, circular, ellipticalcurvilinear, etc. and having dimensions configured to fit betweenelongated traces 30, 32 of soluble pressure sensitive adhesive (PSA).Thickness or diameters of PSA reinforcing zones 40, 45 may range from0.2 mm to 3 mm, such as 0.3, 0.4, 0.5, 1, 2 mm.

Non-soluble shielding film traces 70 have length similar to length ofelongated traces 30, 32 of soluble pressure sensitive adhesive (PSA).The width of shielding film traces 70 may be equal or larger than thewidth of elongated traces 30, 32, such as 3 mm to about 10 mm, morepreferably 3 mm to 6 mm, such as 3, 4, 5 mm.

PSA

Soluble PSA materials are exemplified by water soluble pressuresensitive adhesives, including Hydrocolloids; Homo-polymer Emulsion(PVA); Water-based Acrylic Adhesives; Polyurethane Dispersions PUDs;Poly ethylene glycol; Dextrin/Starch-Based Adhesives; N-vinylcaprolactam homopolymers; N-vinyl pyrrolidone copolymers; polyvinylalcohol; cellulose ethers; methylcellulose; carboxymethylcellulose;polyvinylpyrrolidone; Polyvinyl Acetates.

Insoluble PSA materials are exemplified by water insoluble pressuresensitive adhesives, including Acrylic adhesives; Cyanoacrylateadhesives; Epoxy; Silicone based adhesives; and Urethane.

Initiator

In a preferred embodiment, initiators and/or accelerators or ratemodifiers of adhesive polymerization or cross-linking can be releasablydisposed on tape 20 or releasably incorporated into mesh 20. Forexample, one or more chemical substances may be dispersed in or on tape20 such as being chemically bound, physically bound, coated, absorbed,or adsorbed to it.

For example, a polymerization initiator or accelerator or rate modifiermay be loaded in or on tape 20 so that the initiator or rate modifierprovides the desired initiation or rate modification effect to asubsequently applied polymerizable adhesive composition. Thepolymerization initiator or rate modifier may be immobilized in or ontape 20, so that the initiator or rate modifier does not become detachedfrom tape 20 and its residues are dispersed in the resultant polymericmaterial. Alternatively, for example, the polymerization initiator orrate modifier may be initially attached to tape 20, but only in such amanner that it becomes mobilized or solubilized by a subsequentlyapplied polymerizable adhesive composition and dispersed in theresultant polymeric material.

If desired, a combination of chemical substances may also be provided inor on tape 20, to provide multiple effects. For example, a firstchemical species (such as a polymerization initiator or rate modifier)may be immobilized in or on tape 20, while a second, different chemicalspecies (such as a bioactive material) may be detachably attached totape 20. Other combinations of chemical species and resultant effectsare also envisioned.

When present in or on tape 20, the chemical substances (i.e.,polymerization initiator, rate modifier, and/or bioactive materials, orother additives), may be incorporated in or on tape 20 in any suitablemanner. For example, the chemical substance may be added to tape 20 bycontacting tape 20 with a solution, mixture, or the like including thechemical substances. The chemical substance may be added to tape 20, forexample, by dipping, spraying, roll coating, gravure coating, brushing,vapor deposition, or the like. Alternatively, the chemical substance maybe incorporated into or onto tape 20 during manufacture of tape 20, suchas during molding.

The polymerization initiator or rate modifier loaded in or on tape 20may provide a number of advantages for example, so as to provide fasterpolymerization time. The concentration of polymerization initiator orrate modifier may be increased to provide even faster polymerizationtime.

Because the polymerization initiator or rate modifier is loaded directlyin or on tape 20, it is not necessary to mix the polymerizable adhesivecomposition with a polymerization initiator or rate modifier prior toapplication. This may allow a longer working time, where thepolymerizable monomer composition may be more precisely and carefullyapplied over a longer period of time.

Such suitable initiators are known in the art and are described, forexample, in U.S. Pat. Nos. 5,928,611 and 6,620,846, both incorporatedherein by reference in their entireties, and U.S. Patent Application No.2002/0037310, also incorporated herein by reference in its entirety.Quaternary ammonium chloride and bromide salts useful as polymerizationinitiators are particularly suitable. By way of example, quaternaryammonium salts such as domiphen bromide, butyrylcholine chloride,benzalkonium bromide, acetyl choline chloride, among others, may beused.

Benzalkonium or benzyltrialkyl ammonium halides such as benzyltrialkylammonium chloride may be used. When used, the benzalkonium halide may bebenzalkonium halide in its unpurified state, which comprises a mixtureof varying chain-length compounds, or it can be any suitable purifiedcompound including those having a chain length of from about 12 to about18 carbon atoms, including but not limited to C12, C13, C14, C15, C16,C17, and C18 compounds. By way of example, the initiator may be aquaternary ammonium chloride salt such as benzyltrialkyl ammoniumchloride (BTAC).

Other initiators or accelerators may also be selected by one of ordinaryskill in the art without undue experimentation. Such suitable initiatorsor accelerators may include, but are not limited to, detergentcompositions; surfactants: e.g., nonionic surfactants such aspolysorbate 20 (e.g., Tween20™ from ICI Americas), polysorbate 80 (e.g.,Tween 80™ from ICI Americas) and poloxamers, cationic surfactants suchas tetrabutylammonium bromide, anionic surfactants such as sodiumtetradecyl sulfate, and amphoteric or zwitterionic surfactants such asdodecyldimethyl(3-sulfopropyl)ammonium hydroxide, inner salt; amines,imines and amides, such as imidazole, arginine and povidine; phosphines,phosphites and phosphonium salts, such as triphenylphosphine andtriethyl phosphite; alcohols such as ethylene glycol, methyl gallate;tannins; inorganic bases and salts, such as sodium bisulfate, calciumsulfate and sodium silicate; sulfur compounds such as thiourea andpolysulfides; polymeric cyclic ethers such as monensin, nonactin, crownethers, calixarenes and polymeric-epoxides; cyclic and acycliccarbonates, such as diethyl carbonate; phase transfer catalysts such asAliquat 336; organometallics such as cobalt naphthenate and manganeseacetylacetonate; and radical initiators or accelerators and radicals,such as di-t-butyl peroxide and azobisisobutyronitrile.

Mixtures of two or more, such as three, four, or more, initiators oraccelerators may be used. A combination of multiple initiators oraccelerators may be beneficial, for example, to tailor the initiator ofthe polymerizable monomer species. For example, where a blend ofmonomers is used, a blend of initiators may provide superior results toa single initiator. For example, the blend of initiators can provide oneinitiator that preferentially initiates one monomer, and a secondinitiator that preferentially initiates the other monomer, or canprovide initiation rates to help ensure that both monomer species areinitiated at equivalent, or desired non-equivalent, rates. In thismanner, a blend of initiators can help minimize the amount of initiatornecessary. Furthermore, a blend of initiators may enhance thepolymerization reaction kinetics.

Adhesive

In one embodiment, liquid or semi-liquid adhesive 50 is polymerized oris cross-linked polymerized or is cross-linked after coming in contactwith initiators and/or accelerators of adhesive polymerization and/orcross-linking, including naturally found initiators on the tissue, suchas moisture, traces of proteins, etc.

Such initiators and/or accelerators can be coated or disposednon-releasably, i.e. immobilized in or on the tape 20 while retainingactivity to initiate or accelerate polymerization and/or cross-linking.In one embodiment, initiators and/or accelerators are disposedreleasably, i.e., they can be at least partially released into and mixwith flowing adhesive 50.

In a preferred embodiment, adhesive 50 is polymerized or is cross-linkedafter coming in contact with initiators and/or accelerators releasablydisposed in or on tape 20. Rapid polymerization and/or crosslinking ofadhesive 50 results in bonding of device 10 to tissue.

Adhesive 50 can be any type of biocompatible and rapidly cross-linkableand/or polymerizable compound or mixture of compounds. Rapidlycross-linkable and/or polymerizable means that after initiators oraccelerators are added, or after the adhesive is formed from two or morecomponents, it is capable of curing, i.e. cross-linking and/orpolymerizing within 0.2 min to about 20 min, more preferably within 0.5min to 10 min, such as 1, 2, 3, 5 min.

In one embodiment, adhesive 50 is formed prior to application onto tape20, for instance by mixing two components contained in separate barrelsor a two-barrel syringe, by passing these two components through amixing tip. In this embodiment, there is no crosslinking initiator oraccelerator disposed inside of mesh 20. In one embodiment, adhesive 50is formed by mixing fibrinogen and thrombin together.

In one embodiment, adhesive 50 comprises fibrinogen, and crosslinkinginitiator or accelerator disposed inside of mesh 20 comprises thrombin.

In a preferred embodiment, the polymerizable adhesive composition maycomprise a polymerizable monomeric adhesive. In embodiments, thepolymerizable adhesive composition comprises a polymerizable1,1-disubstituted ethylene monomer formulation. In embodiments, thepolymerizable adhesive composition comprises a cyanoacrylateformulation. In embodiments, synthetic polymerizable adhesive materialssuch as polyurethane, polyethylene glycol, acrylates, glutaraldehyde andbiologically based adhesives may be used.

Suitable .alpha.-cyanoacrylate monomers which may be used, alone or incombination, include alkyl .alpha.-cyanoacrylates such as 2-octylcyanoacrylate; dodecyl cyanoacrylate; 2-ethylhexyl cyanoacrylate; butylcyanoacrylate such as n-butyl cyanoacrylate; ethyl cyanoacrylate; methylcyanoacrylate or other .alpha.-cyanoacrylate monomers such asmethoxyethyl cyanoacrylate; 2-ethoxyethyl cyanoacrylate; 3-methoxybutylcyanoacrylate; 2-butoxyethyl cyanoacrylate; 2-isopropoxyethylcyanoacrylate; and 1-methoxy-2-propyl cyanoacrylate. In embodiments, themonomers are ethyl, n-butyl, or 2-octyl .alpha.-cyanoacrylate. Othercyanoacrylate monomers which may be used include alkyl estercyanoacrylates, such as those prepared by the Knoevenagel reaction of analkyl cyanoacetate, or an alkyl ester cyanoacetate, withparaformaldehyde, subsequent thermal cracking of the resultant oligomerand distillation.

Many other adhesive formulations can be used and are known to a skilledartisan. For example, mixtures containing PEG succinimidyl glutarate canbe used as a flowable adhesive.

It should be understood that the foregoing disclosure and description ofthe embodiments of the present invention are illustrative andexplanatory thereof and various changes in the size, shape and materialsas well as in the description of the preferred embodiment may be madewithout departing from the spirit of the invention.

What is claimed is:
 1. A device for application onto incisions or wounds with a liquid rapidly polymerizable adhesive for forming skin closure systems, comprising a thin flexible flat porous tape elongated along a longitudinal axis and having a lower side or wound facing side and an opposing upper side, a periphery, and central portion in immediate vicinity of the axis; said tape coated or impregnated with an initiator or accelerator of polymerization; said tape having a plurality of elongated traces of soluble pressure sensitive adhesive (PSA) disposed on the wound facing side; said traces covering from about 3% to about 50% of area of said tape and extending from the central portion to the periphery of said tape.
 2. The device of claim 1, further comprising an elongated trace of soluble PSA disposed on the wound facing side which runs along and at least partially overlaps the axis covering the central portion of said tape.
 3. The device of claim 1, further comprising at least one elongated absorbent pad attached to the mesh at the periphery and configured to absorb exudates.
 4. The device of claim 1, wherein said mesh is further having a plurality of insoluble PSA reinforcing zones disposed on the wound facing side; said zones not overlapping with said traces of soluble PSA.
 5. The device of claim 4, wherein said tape has at least 40% of the tape not covered by the traces of insoluble PSA, traces of soluble PSA, or combination of both.
 6. The device of claim 1, wherein a plurality of adhesive-impermeable elongated flat strips is disposed on the top side of said device, said strips extending from the central portion of said mesh to the periphery of said tape, wherein said strips are registered with and are covering the traces of soluble PSA.
 7. The device of claim 1, wherein the accelerator or the initiator comprises quaternary ammonium salt.
 8. The device of claim 1 wherein the adhesive comprises cyanoacrylate monomers, fibrinogen, or PEG succinimidyl glutarate.
 9. A method of using the device of claim 1 on a wound for skin incision closure, comprising the steps: positioning the device of claim 1 with the lower side facing the wound; orienting the axis in alignment with the incision ensuring the axis is approximately overlapping the incision; approximating edges of the incision to each other with the device of claim 1 and adhering the device of claim 1 to the skin; applying a polymerizable adhesive onto the upper side of the tape, allowing the adhesive to penetrate through the mesh and contact the skin; allowing the adhesive to react with the initiator or accelerator of polymerization and polymerize thus bonding the mesh to the skin; and allowing exudates from the wound to at least partially dissolve the traces of soluble pressure sensitive adhesive (PSA) thus forming drainage channels.
 10. A method of making a device for application onto incisions or wounds with a liquid rapidly polymerizable adhesive for forming skin closure systems, comprising the steps: coating a thin flexible flat porous tape elongated along a longitudinal axis and having a lower side or wound facing side and an opposing upper side, a periphery, and central portion in immediate vicinity of the axis with an initiator or accelerator of polymerization; coating said tape on the wound facing side with a plurality of elongated traces of soluble pressure sensitive adhesive (PSA), said traces covering from about 3% to about 50% of area of said tape and extending from the central portion to the periphery to of said tape.
 11. The method of claim 10, further comprising a step of coating said tape on the wound facing side with a plurality of insoluble PSA reinforcing zones disposed on the wound facing side; said zones not overlapping with said traces of soluble PSA.
 12. The method of claim 10, further comprising a step of applying a plurality of adhesive-impermeable elongated flat strips on the top side, said strips extending from the central portion to the periphery of said tape, wherein said strips are registered with and are covering the traces of soluble PSA.
 13. A kit comprising: the device of claim 1, and a container with polymerizable adhesive having a tip for expressing and spreading said polymerizable adhesive onto the tape. 